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Preoperative Use of Tocotrienol From Annatto Bixa Orellana L. in Breast Cancer Patients: a Prospective Clinical Trial. (TOCANNATO)

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ClinicalTrials.gov Identifier: NCT04496492
Recruitment Status : Completed
First Posted : August 3, 2020
Last Update Posted : August 3, 2020
Sponsor:
Information provided by (Responsible Party):
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Brief Summary:

Tocotrienols have shown strong in vitro and in vivo anti-oxidant and anticancer activity, promoting apoptosis and regulating oncogenic targets in breast cancer. However their clinical use is still experimental especially in preoperative setting, where there are still no data of antioxidant and antiinflammatory beneficial roles. This study is a prospective observational clinical study enrolling 50 patients with primary breast cancer (T1-2, N0-1, M0) who received 4-weeks oral treatment of delta-T3 before surgery (200 mg/twice daily) with personalized nutritional and psychoeducational support. This study evaluates the effects of treatment on oxidant (tock fast-Li Starfish) and antioxidant capacity (TAC Track, Li Starfish), anti-inflammatory activity (complete profiling of adaptive and innate cell immunity, immunologic serum markers (miRNA)), immunological response on tumor (gene expression profiling on preoperative tissue tumor biopsy and on surgical specimen), TNF-alpha, IL-6 and VEGF and proliferation/apoptosis, anti-inflammatory and anti-oxidant activity of breast cancer cell lines.

This study evaluates the effects of treatment on oxidant (tock fast-Li Starfish) and antioxidant capacity (TAC Track, Li Starfish), on anti-inflammatory activity (complete profiling of adaptive and innate cell immunity, immunologic serum markers (miRNA)), on immunological response on tumor (gene expression profiling on preoperative tissue tumor biopsy and on surgical specimen), on TNF-alpha, IL-6 and VEGF, on proliferation/apoptosis, anti-inflammatory and anti-oxidant activity of breast cancer cell lines.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Tocotrienol Phase 2

Detailed Description:
An open-label, single center, phase 2 prospective observational clinical study

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoperative Use of Tocotrienol Associated With Personalized Nutritional and Psychoeducational Support in Women With Primary Breast Cancer.
Actual Study Start Date : February 9, 2016
Actual Primary Completion Date : February 9, 2016
Actual Study Completion Date : July 6, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tocotrienol
Subjects receiveTocotrienol 200 mg/twice daily before surgery
Drug: Tocotrienol
Tocotrienol 200 mg orally twice a day




Primary Outcome Measures :
  1. Changes in blood oxidant capacity [ Time Frame: 4 weeks ]
    Oxidant capacity (through tock fast-Li Starfish) (µmol/L) was measured in patients' serum samples.

  2. Changes in blood antioxidant capacity [ Time Frame: 4 weeks ]
    Antioxidant capacity (through TAC Track, Li Starfish) (µmol/L) was measured in patients' serum samples.

  3. Absolute and relative changes in peripheral blood mononuclear cells obtained before and after four weeks of tocotrienol treatment, as detected by 13-colors citofluorimetry analysis [ Time Frame: 4 weeks ]
    Peripheral blood mononuclear cells were measured by 13-color cytofluorimetry analysis in patients' serum samples.

  4. Changes of immune-related miRNA levels in patients' serum samples obtained before and after four weeks of tocotrienol treatment, as determined by quantitative real-time PCR analysis [ Time Frame: 4 weeks ]
    Immune-related miRNA levels were determined by quantitative real-time PCR analysis in patients' serum samples obtained before and after four weeks of tocotrienol treatment

  5. Changes in immune response associated gene levels in preoperative tissue tumor biopsies and in surgical specimens, obtained before and after four weeks of tocotrienol treatment, respectively, as determined by gene expression profiling analysis [ Time Frame: 4 weeks ]
    Immune response associated gene levels were determined by gene expression profiling analysis in preoperative tissue tumor biopsies and in surgical specimens, obtained before and after four weeks of tocotrienol treatment

  6. Changes in serum inflammatory cytokines and growth factor [ Time Frame: 4 weeks ]
    Blood inflammatory cytokines and growth factor (through TNF-alpha (pg/ml), IL-6 (pg/ml) and VEGF (pg/ml) quantifications) were measured in patients' serum samples


Secondary Outcome Measures :
  1. Treatment-induced changes in proliferation/apoptosis, anti-inflammatory and anti-oxidant activity of breast cancer cell lines [ Time Frame: 12,24 and 72 hours ]
    Treatment-induced changes in proliferation/apoptosis, anti-inflammatory and anti-oxidant activity of breast cancer cell lines was measured through cell culture analysis.

  2. Changes in expression of tumor proliferation, hormone receptors and HER2 [ Time Frame: 4 weeks ]
    Expression of tumor proliferation index (Ki67), estrogen and/progesterone receptor and HER2 oncoprotein by IHC was determined in preoperative tumor biopsies and in surgical specimens



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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically confirmed operable primary breast cancer (T1-T2 N0-1 M0)
  • absence of distant metastasis
  • signed informed consent.

Exclusion Criteria:

  • Previous malignancies other than in situ cervical carcinoma or nonmelanoma skin cancer
  • Breast cancer recurrence
  • Metastatic breast cancer
  • Non-epithelial breast cancer at histological examination
  • In situ lobular breast cancer
  • Participation in other randomized clinical trials that could interfere with current study
  • Living distant from center and unable to attend for check-ups and meetings

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04496492


Locations
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Italy
Fondazione IRCCS Istituto Nazionale Tumori
Milano, Italy, 20133
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Investigators
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Principal Investigator: Cristina Ferraris, MD Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Publications of Results:
Donini LM, Cuzzolaro M, Spera G, Badiali M, Basso N, Bollea MR, Bosello O, Brunani A, Busetto L, Cairella G, Cannella C, Capodaglio P, Carbonelli MG, Castellaneta E, Castra R, Clini E, Contaldo F, Dalla Ragione L, Dalle Grave R, D'Andrea F, Del Balzo V, De Cristofaro P, Di Flaviano E, Fassino S, Ferro AM, Forestieri P, Franzoni E, Gentile MG, Giustini A, Jacoangeli F, Lubrano C, Lucchin L, Manara F, Marangi G, Marcelli M, Marchesini G, Marri G, Marrocco W, Melchionda N, Mezzani B, Migliaccio P, Muratori F, Nizzoli U, Ostuzzi R, Panzolato G, Pasanisi F, Persichetti P, Petroni ML, Pontieri V, Prosperi E, Renna C, Rovera G, Santini F, Saraceni V, Savina C, Scuderi N, Silecchia G, Strollo F, Todisco P, Tubili C, Ugolini G, Zamboni M. [Obesity and Eating Disorders. Indications for the different levels of care. An Italian Expert Consensus Document]. Eat Weight Disord. 2010 Mar-Jun;15(1-2 Suppl):1-31. Review. Italian.

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Responsible Party: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT04496492    
Other Study ID Numbers: 2014-005275-92
First Posted: August 3, 2020    Key Record Dates
Last Update Posted: August 3, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tocotrienols
Vitamin E
Tocopherols
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients